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U.S. Department of Health and Human Services

Class 2 Device Recall Biotene Moisturizing Mouth Spray

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  Class 2 Device Recall Biotene Moisturizing Mouth Spray see related information
Date Initiated by Firm October 17, 2013
Date Posted November 13, 2013
Recall Status1 Terminated 3 on July 26, 2017
Recall Number Z-0272-2014
Recall Event ID 66689
510(K)Number K123731  
Product Classification Saliva, artificial - Product Code LFD
Product Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108.

Biotene Mouth Spray is used for the treatment of dry mouth
Code Information UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
Recalling Firm/
Manufacturer		 GlaxoSmithKline, LLC.
1011 North Arendell Ave
Zebulon NC 27597-1217
For Additional Information Contact Randy Pittard
919-269-1194
Manufacturer Reason
for Recall		 Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
FDA Determined
Cause 2		 Labeling Change Control
Action GlaxoSmithKline sent an Urgent Medical Device Recall letter dated October 17, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected product. If product was further distributed customers were instructed notify their customers of the recall and the actions required. Customers were asked to complete and return the enclosed business replay card even if they have no affected product in their inventory. Customers should complete the return goods packing slip, enclose it with their return goods shipment and affix the return label to the package. Customers with questions should call Customers Service at 1-800-743-4014. For questions regarding this recall call 919-269-1194.
Quantity in Commerce 483,204 bottles
Distribution Nationwide Distribution .
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LFD and Original Applicant = GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
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